Palvella completes FDA pre-NDA meeting for QTORIN rapamycin gel in microcystic lymphatic malformations

Palvella

Palvella

PVLA

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  • Palvella Therapeutics completed an FDA pre-NDA meeting for QTORIN rapamycin gel in microcystic lymphatic malformations.
  • Phase 3 SELVA results were already generated and reviewed with FDA, including before-and-after images, supporting a planned NDA in H2 2026.
  • The company characterized the treatment effect as clinically meaningful, positioning the product as a potential first FDA-approved option for the disease.
  • The planned filing relies on existing Phase 3 and Phase 2 data, supported by real-world evidence, with no additional efficacy study planned.
  • QTORIN rapamycin holds FDA Breakthrough Therapy, Orphan Drug, and Fast Track designations for this indication.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Palvella Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606030730PRIMZONEFULLFEED9731219) on June 03, 2026, and is solely responsible for the information contained therein.

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